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Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or b

FDA device recall Z-2395-2012 · posted 2012-09-17 · Terminated

Recall details

Recalling firm
Hospira Inc.
Reason for recall
Embedded iron oxide glass defect which may have the potential to break off into the solution.
Action taken
Hospira sent an "URGENT DEVICE RECALL" dated August 28, 2012 to all affected customers. The letter identified the product, problem,and actions to be taken by the customers. The letter included an Urgent Device Recall Reply Form for customers to complete and return via fax to 1-888-237-5582. Contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.
Root cause
Material/Component Contamination
Status
Terminated
Product code
KPE
Quantity affected
191,094 units
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.
Date initiated
2012-08-28
Date posted
2012-09-17
Date terminated
2013-09-18
Location
Lake Forest, IL

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